NCT01742052已完成2 期
A Phase II, Multicentre, Randomised, Double-blind,Parallel Group, Placebo-controlled, Dose-finding Study to Evaluate the Safety and Efficacy of Three Different Oral Doses of MT-1303 Administered for a Period of 24 Weeks in Subjects With Relapsing-remitting Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 415
- 试验地点
- 1
- 主要终点
- The total number of MRI Gd-enhanced T1-weighted lesions
研究概览
简要总结
The primary objectives of the study are:
- To evaluate the effects of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI parameters
- To evaluate the safety and tolerability of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with RRMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RRMS as defined by the revised McDonald criteria
- •Evidence of recent MS activity defined as either:
- •at least one documented relapse in the previous 12 months, OR
- •a positive gadolinium (Gd)-enhanced MRI scan within 3 months prior to screening, OR
- •at least two documented relapses in the previous 24 months with a positive Gd-enhanced MRI scan within the previous 12 months
- •Expanded Disability Status Score (EDSS) score ≥0.0 and ≤5.5 points.
排除标准
- •Primary progressive, secondary progressive or progressive relapsing MS at screening
- •Disease duration >15 years combined with an EDSS score ≤2.0
- •Relapse of MS during the Screening Period
- •History or known presence of other neurological disorders likely to render the subject unsuitable for the study
- •History of any of a list of pre-defined cardiovascular diseases
- •History or known presence of any significant central nervous system, infectious, metabolic, oncological, ophthalmological or respiratory system disease or illness likely to render the subject unsuitable for the study
- •Previous exposure to any sphingosine 1-phosphate receptor modulator
- •Receipt of a live vaccine or systemic corticosteroid use within 28 days prior to randomisation
- •Previous treatment with beta-interferons or glatiramer acetate within 14 days prior to randomisation
- •Previous treatment with intravenous immunoglobulin, plasmapheresis, certain immunosuppressants, lymphocyte-depleting therapy, total body irradiation or bone marrow transplantation
- •Need, or likely need for, treatment with Class I or III anti-arrhythmic drugs or with heart-rate-lowering beta-blockers or calcium-channel blockers, or with any other drugs which can reduce the heart rate
- •Evidence of significant anaemia, thrombocytopenia, leucopoenia or lymphocytopenia, renal or hepatic impairment
- •Clinically significant electrocardiogram (ECG) findings.
研究组 & 干预措施
MT-1303-Low
Experimental
MT-1303-Low Dose
干预措施: MT-1303-Low (Drug)
MT-1303-Middle
Experimental
MT-1303-Middle Dose
干预措施: MT-1303-Middle (Drug)
MT-1303-High
Experimental
MT-1303-High Dose
干预措施: MT-1303-High (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The total number of MRI Gd-enhanced T1-weighted lesions
时间窗: Weeks 24
次要结局
未报告次要终点
研究者
研究点 (1)
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